None listed
Conditions
Interventions
Drug : ? Experimental Group
A person who weighs more than 50kg and has a weight within ± 20%
of the ideal body weight(Healthy adult male aged 19 to 45)
?The evidence of selection of test group
Unlike the typical statistical hypothesis test, this study is a clinical trial to evaluate the safe
Sponsors
Woosung Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects enrolled in this study must meet all of the following selection criteria: 1)Healthy adult males between 19 and 45 years old at the time of screening 2)A person who weighs more than 50kg and has a weight within ± 20% of the ideal body weight 3) A person who voluntarily decides to participate in a clinical trial and agrees to follow precautions after hearing a detailed description of the trial
Exclusion criteria
Exclusion criteria: Subjects enrolled in this study are excluded if any of the following exclusion criteria apply. 1)Person who is unable to collect blood up to 7ml / kg per day as required by this study 2) Drugs containing acetaminophen (paracetamol) or propacetamol within 24 hours prior to clinical trial drug administration and within 12 hours prior to screening, or drugs containing probenecid, isoniazide within 48 hours And if you received medication containing disulfiram within a month 3) Patients with severe hepatic impairment or total bilirubin measured more than 1.5 times the normal upper limit of the clinical laboratory or whose ALT or AST is 2.5 times higher than the normal upper limit 4) Patients with severe renal impairment or those with an estimated glomerular filtration rate (eGFR) of 1/3 or less of the normal lower limit of the clinical laboratory 5) Patients with symptoms suspected of acute disease 28 days before the start of trial (clinical administration) 6) Patient Who has History that can affect the absorption, distribution, metabolism, and excretion of drugs(Cardiovascular system, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, mental illness, or malignant tumor.) 7) Applicants deemed unsuitable as subjects through Health examination conducted within 28 days of start of trial (Screening items such as paperweight, blood pressure, 12-lead ECG, physical examination, blood, urine test) 8) Patients with Bilateral renal artery stenosis, renal artery stenosis in a single kidney, or only one side of the kidneys functioning, such as those who show abnormalities in renal function in the past 9) Patients with Clinically significant allergic disease(Excluding mild allergic rhinitis that does not require medication) 10) Those who have a history of hypersensitivity to drugs(Acetaminophen or NAC) 11) Participants in other clinical studies(Clinical Drug Administration) within 60 days of trial 12) Patient who took a specialty medication within 14 days of the start of the trial or a generic drug within 7 days of the start of the trial so that the investigator's judgment that the taking medication affects the test or the safety of the subject 13) Those who have had an abnormal meal that may affect the absorption, distribution, metabolism and excretion of the drug 14) Patient who has symptomatic systolic / diastolic blood pressure less than 110/60 mmHg in supine position(E.g. dizziness) 15) Patient who is unable to eat standard meals provided by the clinical institution 16) Those who donated whole blood within 60 days after the test or donated component blood donations within 30 days 17) People who continue to drink caffeine(Caffeine> 5 cups / day) or are unable to drink(Alcohol> 30g / day) during the clinical trial or are excessive smokers (Tobacco> 10 cigarettes / day) 18) A person who has judged that it is inappropriate according to the tester's judgment for other reasons. 19) Patient with aspirin asthma (induced asthma attack by nonsteroidal anti-inflammatory (anti-inflammatory)) or history of it 20) Those who have taken drug metabolism inducing and inhibitory drugs such as barbital drugs within 1 month before starting the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic properties of acetaminophen alone [1st] and acetaminophen & NAC combined [3rd];Pharmacokinetics of NAC alone administration [2nd] and acetaminophen & NAC combination administration [3rd] | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation after acetaminophen and NAC alone or in combination | — |
Countries
Korea, Republic of
Contacts
Public ContactJintae Kim
Seoul National University
Outcome results
None listed